A Phase 4 interventional study of Treatment with HBS 2 Resorb Mg in Intraarticular Fracture, Extraarticular Fracture and Pseudarthrosis, sponsored by KLS Martin. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by KLS Martin · Phase 4, Interventional, and Treatment
This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's planned enrollment of 60 is above the median of 22 across 25 interventional studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →This is the only study on the registry with KLS Martin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study arm treated with the HBS 2 Resorb Mg.
Device: Treatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Bony Fusion (Change)
The primary endpoint of the study is the fusion rate of the bone. After the onset of bony fusion, the implant no longer fulfils any function, and it should be resorbed.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Secondary displacement and breakage of the implant (YES/NO)
Any secondary radiographic displacement or breakage of the implant or any clinically significant loss of reduction is noted.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Deep infection(YES/NO)
The presence of deep infections is assessed binary.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Clinical outcome
Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Surgical revisions(YES/NO)
As typically one single surgery should be sufficient to treat the patient, all secondary surgical interventions are revisions due to a complication. This includes also re-operation due to screw removal.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Early corrosion phenomenon(YES/NO)
Symptomatic gas accumulation or formation of gas pockets due to degradation of the material.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Radiolucency(YES/NO)
Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon.
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2025, 37 months after the start.
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